- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07632352
Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma
2 juni 2026 uppdaterad av: Henan University of Traditional Chinese Medicine
Evaluation of Clinical Effect of Acupuncture on Acute Exacerbation of Bronchial Asthma Based on Biological Holography Theory
Based on the bioholographic theory, this study preliminarily explores the clinical efficacy of hand acupuncture in treating acute exacerbation of bronchial asthma and evaluates its immediate anti-asthmatic effect, so as to provide a new therapeutic strategy for the clinical management of bronchial asthma.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
This study adopted a randomized controlled trial design, with patients in the acute exacerbation phase of bronchial asthma as the research subjects.
A total of 72 patients who met the inclusion criteria were randomly divided into the acupuncture group and the control group in a 1:1 ratio.
The control group received standard Western medicine treatment, while the acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment.
The acupoints selected were Kechuan point, New Kechuan point, and Yuji point.
The treatment was administered once a day for 20 minutes each time, for 5 consecutive days, with a 3-month follow-up.
The therapeutic efficacy of manual acupuncture in treating acute exacerbation of bronchial asthma was evaluated with indicators including symptom and sign scores, pulmonary function, ACT , mMRC , Mini-AQLQ scale, serum interleukin-4 (IL-4), serum eotaxin and specific immunoglobulin E (SIgE).
In addition, the underlying therapeutic mechanism was preliminarily explored to formulate a technical protocol for rapid anti-asthma acupuncture, laying a foundation for long-term and objective efficacy evaluation of this therapy.
Studietyp
Interventionell
Inskrivning (Beräknad)
72
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Qinmei Yang
- Telefonnummer: 15981845716
- E-post: yangqinmei840105@126.com
Studieorter
-
-
Henan
-
Zhengzhou, Henan, Kina, 450000
- Rekrytering
- The First Affiliated Hospital of Henan University of Chinese Medicine
-
Kontakt:
- Qinmei Yang
- Telefonnummer: 15981845716
- E-post: yangqinmei840105@126.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
Inclusion Criteria:
- Patients meeting the Western medicine diagnostic criteria for acute exacerbation of bronchial asthma
- Aged ≥ 18 years old
- Voluntarily receive treatment and sign the informed consent form
Exclusion Criteria:
- Those who fail to meet the inclusion criteria
- Patients suffering from other severe systemic diseases such as diseases of the circulatory system, hematological system and nervous system
- Pregnant or lactating women
- Subjects enrolled but not treated per the study protocol
- Patients who have participated in other clinical trials of medicinal products within 3 months
- Other circumstances deemed ineligible for enrollment by researchers
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: acupuncture group
The acupuncture group was given acupuncture treatment based on biological holography theory in addition to the standard Western medicine treatment.
The acupoints selected were Kechuan point, New Kechuan point, and Yuji point.
The treatment was administered once a day for 20 minutes each time, for 5 consecutive days
|
The acupoints selected were Kechuan point, New Kechuan point, and Yuji point.
The treatment was administered once a day for 20 minutes each time, for 5 consecutive days.
Evaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ).
|
|
Aktiv komparator: control group
The control group received standard Western medicine treatment
|
Evaluate and manage in accordance with the Chinese Expert Consensus on Assessment and Management of Acute Exacerbation of Bronchial Asthma issued by the Asthma Group of the Chinese Thoracic Society, Chinese Medical Association in 2018 and the Guidelines for the Prevention and Treatment of Bronchial Asthma (2020 ).
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Peak Expiratory Flow(PEF)
Tidsram: After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
PEF will be used to assess pulmonary function
|
After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
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Asthma Control Test
Tidsram: After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
The ACT score consists of 5 questions, each scored from 1 to 5 points, with a total score ranging from 5 to 25 points; lower scores indicate more severe symptoms.
|
After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Forced expiratory volume in first second/pred(FEV1%pred)
Tidsram: After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
FEV1%pred will be used to assess pulmonary function
|
After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
|
Clinical Symptom and Sign Score
Tidsram: After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
It includes six symptoms: cough, expectoration, chest tightness, wheezing, shortness of breath and wheeze.
Scores of 0, 3, 6 and 9 are assigned according to the severity of symptoms, with higher scores corresponding to more severe symptoms.
|
After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
|
Mini Asthma Quality of Life Questionnaire(Mini-AQLQ)
Tidsram: After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
It consists of 15 questions, each scored on a scale from 1 to 7 based on the severity of symptoms and their degree of impact.
A score of 1 indicates no symptoms or no adverse impacts, while a score of 7 stands for severe symptoms or substantial impairment.
Lower total scores correspond to a higher quality of life.
|
After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
|
modified Medical Research Council (mMRC)
Tidsram: After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
Scores range from 0 to 4 based on the severity of dyspnea, with higher scores indicating more severe symptoms.
|
After treatment on Day 5 and follow-up at 1, 2 and 3 months
|
|
Interleukin 4 (IL-4)
Tidsram: After treatment on Day 5
|
Detect the level of IL-4 in peripheral blood
|
After treatment on Day 5
|
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Eotaxin
Tidsram: After treatment on Day 5
|
Detect the level of Eotaxin in peripheral blood
|
After treatment on Day 5
|
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IgE
Tidsram: After treatment on Day 5
|
Detect the level of IgE in peripheral blood
|
After treatment on Day 5
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 april 2025
Primärt slutförande (Beräknad)
15 september 2026
Avslutad studie (Beräknad)
1 januari 2027
Studieregistreringsdatum
Först inskickad
2 juni 2026
Först inskickad som uppfyllde QC-kriterierna
2 juni 2026
Första postat (Faktisk)
8 juni 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
8 juni 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
2 juni 2026
Senast verifierad
1 juni 2026
Mer information
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